An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease

Crohn Disease Clinical Trial

Official title:

A Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269841
• Other study ID #: CR006253
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2005
• Last updated: November 3, 2014
• Start date: May 1996
• Est. completion date: February 1998

Study information

• Verified date: November 2014
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease.

Description:

This is a randomized, placebo-controlled, double-blind, repeated-dose study to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease. The primary efficacy outcome of the study is the number of patients with at least a 50% reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits.

Patients will be treated with either anti-TNF chimeric monoclonal antibody (cA2) or matching placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 1998
• Est. primary completion date: February 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with Crohn's disease of at least 3 months duration confirmed by radiography orendoscopy

• Having single or multiple draining enterocutaneous (including perianal) fistulae of at least 3 months duration

• If treated with oral prednisone (or equivalent), the dose must be <=40 mg/day and must have been stable for at least 3 weeks prior to enrollment. (If currently not treated with oral prednisone, the stop date must have been at least 4 weeks prior to enrollment)

• If treated with 6-mercaptopurine or azathioprine, the start date must have been at least 6 months prior to enrollment. (The dose must have been stable for at least 8 weeks prior to enrollment. If currently not treated with 6-mercaptopurine or azathioprine, the stop date must have been at least 4 weeks prior to enrollment.)

Exclusion Criteria:

• Patients with local complications of Crohn's disease such as strictures or abscesses that might confound the evaluations of the benefit from cA2 treatment

• Having abscesses that should be drained prior to enrollment, with at least 3 weeks between drainage of the abscess and enrollment

• Having a serious infection, such as hepatitis, pneumonia or pyelonephritis, in the previous 3 months or a history of opportunistic infection such as herpes zoster within 2 months prior to screening, or evidence of active cytomegalovirus, active pneumocystis carinii, or drug resistant atypical mycobacterium

• Currently having signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease

• Currently having any known malignancy or any history of malignancy within the past 5 years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Infliximab 10 mg/kg
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.
• Infliximab 5 mg/kg
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.
• Placebo
Matching placebo will be adminstered at Week 0, 2 and 6.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

References & Publications (1)

Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999 May 6;340(1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with 50% or more reduction from baseline in the number of open fistulae at Week 3	Number patients with 50% or more reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits that is not accompanied by initiation of a therapeutic agent or increase in dose.	Week 3	No
Secondary	Percentage of patients achieving a complete response at week 52	The percentage of patients achieving a complete response; In patients responding to treatment, the median time to first observed reduction from baseline of 50% or greater in the number of open fistulae	Week 52	No